Mandatory childhood vaccination could cause “irreparable damage,” says expert panel
BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l5995 (Published 11 October 2019) Cite this as: BMJ 2019;367:l5995All rapid responses
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Before considering implementing mandatory vaccination to remedy the falling rates of vaccine uptake and confidence in vaccine safety it may be prudent to consider all the practical issues associated with vaccines which are perhaps, contributing to the overall reticence of the public to embrace vaccination.
The role of the MHRA is used time and time again to reassure a concerned public as to vaccine safety. The public need to be reassured that the highest possible standards are employed in both collating data and responding to ADR’s. Establishing that is pivotal to the overall levels of vaccine uptake.
The public have the rightful expectation that the MHRA will respond immediately and effectively to any safety issues flagged up. Collating the information alone doesn’t satisfy the public’s expectations. With daily coverage of falling vaccine rates and loss of vaccine confidence it is vital that the standard of post marketing surveillance and resultant action in respect of unsafe products is swift and consistent.
Apparent inconsistencies in what constitutes a problematic, unsafe product with subsequent removal from the market will not reassure the public and instil confidence.
Two relatively recent FOIA disclosures appear to display very different standards between the criteria employed in medicines and vaccines triggering their removal from the market.
Under FOIA, the MHRA confirmed 1076 suspected ADR reports in the under 5’s between 1st January 2005 and 31st December 2015, following administration of the MMR vaccine. (1)
Reports are categorised as to their seriousness under criteria from the “working group of the Council for International Organizations of Medical Sciences (CIOMS) and are defined as 6 possible categories which are documented on the Yellow Card”
The criteria are: “(1) patient died due to reaction (2) life threatening (3) resulted in hospitalisation or prolonged inpatient hospitalisation (4) congenital abnormality and (5) involved persistent or significant disability or incapacity or (6) if the reaction was deemed medically significant.” (1)
Breakdown of the “serious” ADR’s (626) from the 1076 are……….
Patient Died 8
Hospitalised Due To Reaction 143
Life Threatening 27
Disability/Incapacity 67
Congenital Abnormality 0
Other Medically Significant 381
However, a 2017 FOIA (17/460) from the MHRA confirmed that since it came into being in 2003, only 12 medicinal products and no vaccines have been removed from the UK market due to “safety concerns”.(2)
Three of the 12 products listed were removed because of “increased risk of cardiovascular side effects”, two for “liver toxicity”, one for MI/stroke, one for serious skin reactions, one for psychiatric reactions, one for toxicity in overdose, one for risk of abuse/addiction, one for PML and one for “increased incidence of non-fatal serious adverse events and lack of efficacy”.
Risks of abuse and or addiction to any medicine are themselves a matter of concern and a very good reason for removing it from the market but it is understandable that an uneasy public might question why 8 deaths and 67 cases of disability following the administration of the MMR vaccine in under 5’s did not result in it too, being removed from the market.
How can the public be expected to have confidence in a system which appears inconsistent in its approach to what constitutes an actionable safety risk?
Is there a different standard employed by the MHRA with regard to product safety between other medicinal products and vaccines?
Before employing draconian measures of enforced vaccination it may be worth addressing how much of an impact a lack of confidence in the post marketing surveillance is contributing to the overall problem. It seems very unfair to foist the entire burden of the perceived remedy to the problem on to the children and their families if one of the causes of the problem lies elsewhere and a different remedy is called for.
(1) https://www.whatdotheyknow.com/request/322242/response/796748/attach/htm...
(2) https://www.whatdotheyknow.com/request/432947/response/1069707/attach/ht...
Competing interests: No competing interests
I note the letters of Selwyn and Melanie D'Costa as well as Allan Cunningham [1], but while many professionals have an awareness of the limitations of influenza vaccines there may be quite similar issues with measles. Not only has the measles vaccine reduced the general level of immunity in the population [2] it may have caused the evolution of the B3 strain which is apparently less susceptible to the vaccine [3], and has resulted the loss of the UK's "WHO measles free status" [4]. It would be disturbing if experts and officials who are aware that there is problem are allowing it to be blamed on the unvaccinated, when it is the programme itself which needs scrutiny.
We wonder what our politicians are being told by their advisers?
[1] Responses to Mahase, 'Mandatory childhood vaccination could cause “irreparable damage,” says expert panel', https://www.bmj.com/content/367/bmj.l5995/rapid-responses
[2] John Stone, 'Measles vaccination has substituted one problem for another', 20 June 2019, https://www.bmj.com/content/365/bmj.l2359/rr-19
[3] Melenotte C, Zandotti C, Gautret P, Parola P, Raoult D., 'Measles: is a new vaccine approach needed?', Lancet Infect Dis. 2018 Oct;18(10):1060-1061. doi: 10.1016/S1473-3099(18)30543-7.
[4] Amy Hunt, 'Why has the UK lost ‘measles-free’ status – and vaccines could become ‘compulsory’, Good to Know September 30, 2019.
Competing interests: No competing interests
Selwyn and Melanie D'Costa make a very important point. Vaccine authorities would save more lives and misery if they were more selective about the vaccines they promote and mandate.
Measles vaccine is a true lifesaver. Influenza vaccines, on the other hand, are of very uncertain benefit, notwithstanding the host of observational studies announcing this or that percentage of "vaccine effectiveness." Nearly 20 years ago Kenneth McIntosh wrote an editorial calling for multi-center, multi-season, randomized, controlled trials before recommending routine annual influenza vaccination for children. He worried that such a practice would actually do more harm than good. (NEJM 2000;342:275) His advice was ignored, and today we know that influenza vaccines sometime increase the risk of influenza and non-influenza virus infections; they have also caused narcolepsy, febrile seizures, and oculorespiratory syndrome. They provide short-term immunity and prevent some illnesses from seasonal influenza, but in so doing they prevent the development of broad and lasting immunity against influenza viruses, in individuals and in the population as a whole. The frequently quoted observational studies exaggerate the benefits of influenza vaccines and understate the adverse effects because of the "healthy user effect."
In the US the morbidity and mortality from influenza have certainly not declined after years of promoting influenza vaccines for the entire population. Instead of admitting this fact, and the possibility that the vaccines have done more harm than good, US vaccine authorities are now publicizing the hopes for a universal influenza vaccine. Meanwhile, they tell us that, "although flu shots are not perfect, you should get them every year."...…….Measles vaccine YES....influenza vaccine NO.
Competing interests: No competing interests
The flu vaccine is essentially compulsory for most health care staff in the UK following a carrot and stick policy by the Department of Health. The vaccine protection is far inferior to that afforded by the MMR vaccine.
On one hand doctors are prepared to accept a vaccine with questionable benefits about its efficacy as show during the flu outbreak last year but are unwilling to put their name forwards to a vaccine which will undoubtedly save lives.
I would have hoped that the RCPCH had sought the views of its members before unilaterally dismissing compulsory vaccination.
Competing interests: No competing interests
Allan Cunningham, as usual, raises some formidable points [1]. What is apparently at stake is defence against measles but what is really at stake when we talk about mandates or compulsion is total public compliance with as many products as a government bureaucracy cares to nominate. As I mentioned in an earlier response to him the cost of vaccinating a single child according to the schedule has risen by probably more than 100 times since the beginning of the millennium [2]. Already, when there are only multivac products available for many diseases, there is a major diminution of public choice, but if the public have to have everything potentially an industry produces (as is increasingly the case already in the United States and is perhaps proposed by the European Commission [3]) then we have entered the realms of extreme tyranny and thoughtlessness. The very fact that public debate about it is being widely stamped on is itself a matter for deep concern and mistrust. In the United Kingdom we have a pitiful record of recognising vaccine harm (nowhere in the world is it excellent) and opprobrium is perpetually heaped on anyone who mentions it.
While the prevention of disease may in itself be a good thing, it cannot be a pretext for removing the most basic human rights, or ignoring human dignity. We seem to have forgotten everything we ever learned in the 74 years since the Second World War [4]. I see no evidence as I look around that the governments of the world have really become so benign and wise that we can just defer to them in this way. Matt Hancock and Simon Stevens, if they are going to talk about compulsion, need to be much clearer about their intentions.
[1] Allan S Cunningham, 'Too much safety: vaccine mandates, hesitancy, and AFM' 14 October 2019, https://www.bmj.com/content/367/bmj.l5995/rr-1
[2] John Stone, 'Re: The Boiling Frog Principle: patient safety and vaccines', 20 September 2019, https://www.bmj.com/content/366/bmj.l5576/rr-4
[3] European Commission, 'ROADMAP FOR THE IMPLEMENTATION OF ACTIONS BY THE EUROPEAN COMMISSION BASED ON THE COMMISSION COMMUNICATION AND THE COUNCIL RECOMMENDATION ON STRENGTHENING COOPERATION AGAINST VACCINE PREVENTABLE DISEASES', https://ec.europa.eu/health/sites/health/files/vaccination/docs/2019-202...
[4] Wendy E Stephen, 'Re: Mandatory childhood vaccination could cause “irreparable damage,” says expert panel', 14 October 2019, https://www.bmj.com/content/367/bmj.l5995/rr-0
Competing interests: No competing interests
TOO MUCH SAFETY: VACCINE MANDATES, HESITANCY AND AFM
“We all strive for safety, prosperity, comfort, long life…but too much safety seems to yield only danger in the long run.” So said Aldo Leopold, an American wildlife ecologist writing about the control of predators more than 70 years ago. (A Sand County Almanac 1949) The principle applies to our zealous attempts to control microbial pathogens: excessive hygiene, overuse of antibiotics, and aggressive vaccination programs. It relates to the “irreparable damage” caused by vaccine mandates. (Mahase, BMJ 2019;367:l5995, October 11) It may also relate to acute flaccid myelitis/AFM.
On October 7 the CDC reported that the number of confirmed AFM cases in the US had climbed to 590 since recording first began in August 2014. (CDC, AFM Investigation) The actual number of cases is probably much higher. This devastating “mystery disease” is probably caused by non-polio enteroviruses, but based on what we know about poliomyelitis it is likely that IM injections—vaccines or antibiotics—are provoking co-factors. (Cunningham, BMJ rapid responses since January 2015) I have been in touch with CDC officials and AFM Task Force members, who acknowledge the possibility but so far have declined to test the hypothesis. Meanwhile, the popular press continues to report about confusion, mystery and menace as they write poignantly about AFM cases. (Jeffrey Kluger, TIME, 9 October 2019)
It is tragic when mandates and vaccine hesitancy lead to rejection of true lifesavers such as measles vaccine. It is also tragic when rigid mandates, such as those imposed in the US, lead to terrible adverse effects for the sake of the relatively small benefits of some of the other vaccines.
Too much safety seems to yield only danger in the long run….
ALLAN S. CUNNINGHAM 14 October 2019
Competing interests: No competing interests
“Making it mandatory for children to be vaccinated could result in “irreparable damage” by turning the decision whether to vaccinate into a rights issue, a panel of experts has argued”.
Mandatory vaccination might well turn the decision whether or not to vaccinate into a rights issue with the obvious loss of choice but since there is no such thing as a risk free vaccine and the possibility exists for some children to become injured because of it, the authorities would have to give consideration to all human rights and question whether or not in enforcing vaccination, they risk violating any of the rights bestowed on children.
A number of rights safeguard children, preserve their rights to mental, physical and social health, and their ability to participate in a family life.
Dr David Elliman, was reported in the Family Law Week as having said there is no such thing as a vaccination which is 100% risk free.
“Dr Elliman acknowledged that no vaccination is 100% risk free, but that vaccination has greatly reduced the burden of infectious disease”. (1)
And he is not alone in that, with numerous other bodies stating the same, ranging from The Oxford Vaccine group (2) , the WHO (3), The British Society of Immunology (4) the College of Physicians of Philadelphia (5) and more recently in June 2019, Baroness Barran (6)
Realistically, despite every effort to ensure vaccine safety, some children will suffer lasting injuries because of it. Consideration would need to be given to whether or not compulsory vaccination, in the event that something goes wrong, would violate the rights bestowed on children via various conventions etc, not to be harmed.
Article 2 of the Human Rights Act ensures that no one can end a life but it also requires states parties to “safeguard life”.
It provides that "Everyone's right to life shall be protected by law" and includes…………….
“A duty to protect people against the risk of harm from the activities of public authorities” (7)
Since there is no such thing as an entirely risk free vaccine, is it possible that enforced vaccination, if it resulted in a lasting injury, would be a violation of Article 2?
Article 8 provides everyone with a right to a “private and family life,” and ensures
“no interference by a public authority with the exercise of this right”. (8)
Mr Alfred Morris MP, summed it up precisely when he said “all of us must agree that, by definition of the word “family”, if one member of the family is disabled the family as a whole is disabled ,“ something which, was recognised in the Department of Health, Green Book, Chapter 10 on the Vaccine Damage Payment Scheme up until 2016.
Recognising the involvement of the family as a whole, it was stated that an award was intended to “ease the present and future burdens of the vaccine damaged person and their family” (9)
Mandatory vaccination would surely need to include consideration of Article 8 and the impact on family life for both the disabled individual and the family in cases of vaccine induced injury.
Could mandatory vaccinations, in the event of a vaccine injury, be perceived as “an interference of a public authority” re the right to a family life?
Article 24 of The United Nations Convention on the rights of the Child, ensures children have the “best possible health” defined in the 1946 Constitution of the World Health Organisation (WHO), as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. (10)
Proposals to implement mandatory vaccination would need to include consideration of Article 24 in respect of the children whose health, whether mentally, physically, or socially may be negatively affected by a vaccine.
Article 36 protects the child from “any activity that takes advantage of them or could harm their welfare and development” which would surely include any vaccine induced harm which impacts on their well being and their development?
Consideration of any anticipated “irreparable damage” from the implementation of mandatory vaccination needs to include consideration of any potential violations of children’s human rights.
(1) https://www.familylawweek.co.uk/site.aspx?i=ed191684
(2) http://vk.ovg.ox.ac.uk/vk/faqs-about-vaccines
(3) https://vaccine-safety-training.org/overview-and-outcomes-3.html
(4) Vaccines The British Society for Immunology
https://www.immunology.org › sites › default › files › vaccines-policy-brie..
(5) https://www.historyofvaccines.org/index.php/content/articles/vaccine-inj... compensation-programs
(6) https://hansard.parliament.uk/lords/2019-06-18/debates/39F33102-C79A-4FC...
(7) https://justice.org.uk/article-2/
(8) http://www.legislation.gov.uk/ukpga/1998/42/schedule/1/part/I/chapter/7
(9) Department of Health Green Book Chapter 10 June 2014
(10) Office of the United Nations High Commissioner for Human Rights
The Right to Health
Fact sheet 31
Competing interests: No competing interests
Little more than a year ago David Oliver wrote in reply to me in these columns asking what the government should do regarding vaccination [1,2]. He may or may not have found my answer constructive but my "bottom line" at the time was this [3]:
"If I was Secretary of State for Health and Social Care I would certainly be backing off mandates (which would be socially divisive) or compulsion, and I would want greater distance between myself (including all the offices of government and state), and the lobby. Also we can see how the swine flu episode in 2009 (and it’s pre-curser the avian flu episode) distorted public policy: we do not need a repetition."
And yet since the beginning of the year we have had nothing but confrontation [4] and horror stories [5] with major clamp downs on social media, and ever more strident rhetoric about the recalcitrant public from government sources, the WHO etc. Today, in the the Daily Mail Simon Stevens, CEO of NHS England is calling for a clamp down on parents speaking to each other at school gates [6]. My own guess is that he is shooting himself in the foot, and that this will be as welcome as the outgoing Chief Medical Officer's suggestion that the consumption of food and drink be banned on public transport [7]. When public health declares war on the public we have a problem. If we cannot have conversations at the school gates the battle for hearts and minds has well and truly been lost. How did we get to this folly?
Finally, if government refuses to trust the public over informed consent it has lost the moral argument [8].
[1] David Oliver, 'Re: Measles: Europe sees record number of cases and 37 deaths so far this year', 28 August 2018, www.bmj.com/content/362/bmj.k3596/rr-13
[2] David Oliver, 'Re: Measles: Europe sees record number of cases and 37 deaths so far this year', 1 September 2018,
https://www.bmj.com/content/362/bmj.k3596/rr-17
[3] John Stone, 'Re: Measles: Europe sees record number of cases and 37 deaths so far this year', 2 September 2018,
https://www.bmj.com/content/362/bmj.k3596/rr-18
[4] Abi Rimmer, 'NHS chief attacks anti-vax “fake news” for falling uptake', BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l1000 (Published 04 March 2019)
[5] John Stone, 'Information and Misinformation: the Global Health Security Agenda', 5 March 2019, https://www.bmj.com/content/364/bmj.l981/rr
[6] Simon Stevens, 'We MUST stop school gates being a breeding ground for MMR myths', Daily Mail 12 October 2019, https://www.dailymail.co.uk/news/article-7564673/We-stop-school-gates-br...
[7] John Stone, 'Banning food on public transport: a Stalinist approach to health?', 10 October 2019, https://www.bmj.com/content/367/bmj.l5945/rr
[8] Responses to Iacobucci, 'Child vaccination rates in England fall across the board, figures show', https://www.bmj.com/content/366/bmj.l5773/rapid-responses
Competing interests: No competing interests
Trust is not being earned
Thank you Wendy Stephen [1]. The state asserts that vaccines are safe [2] but this can only apparently be achieved by ignoring instances of harm and treating anyone who raises concerns as if they are a public enemy, when in fact it might it be a civic duty. Neither Simon Stevens or Matt Hancock are medical scientists or doctors yet they show every sign of wanting to intimidate or coerce the public. How can we have good medical science if people are perpetually beaten into silence over their experiences (thus destroying any evidence base) and how can we have healthy politics? To have good medical science you have to listen, and you have to pay attention to negative signals: there are hundred, perhaps thousands of peer reviewed papers which do not support the outright safety of vaccine products, no evidence has been produced that any products on the schedule were ever subjected to double blind safety pre-market testing [3] - there are in fact the Patient Information Leaflets - and yet the British state is increasingly unable to recognise any damage at all. This is perhaps not safety first, but simply "gung-ho".
Meanwhile, all is not well with the child population, which is viewed not as a medical problem but simply as some unexplained educational crisis [4].
[1] Wendy E Stephen, 'Re: Mandatory childhood vaccination could cause “irreparable damage,” says expert panel', 24 October 2019, https://www.bmj.com/content/367/bmj.l5995/rr-6
[2] ‘Why vaccination is safe and important’ (media reviewed 30 July 2019), https://www.nhs.uk/conditions/vaccinations/why-vaccination-is-safe-and-i...
[3] John Stone, 'Re: Response to John Stone (2019 Jul 24)', 29 July 2019, https://www.bmj.com/content/365/bmj.l4291/rr-37
[4] Rosemary Bennett, 'Parents despair at special needs ‘chaos’', The Times 23 October 2019.
Competing interests: No competing interests